IPSEN, OOO

Ipsen’s Phase III CONTACT-02 trial of Cabometyx with Roche’s Tecentriq in mCRPC failed to meet OS improvement at 24 months, leading to no regulatory submissions for the combo therapy. Despite this, Exelixis plans to submit a supplemental new drug application to the FDA for the combo in mCRPC.

Cabometyx® (cabozantinib) showed significant reduction in disease progression or death risk in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NETs) compared to placebo, according to data from the CABINET Phase III trial. The results were presented at ESMO 2024 and published in the New England Journal of Medicine. Ipsen has submitted an extension of indication Marketing Authorization to the European Medicines Agency.

Cabometyx (cabozantinib) showed significant reduction in disease progression or death risk in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NETs) compared to placebo, according to final data from the CABINET Phase III trial. Ipsen has submitted an extension of indication Marketing Authorization to the European Medicines Agency. The data were presented at ESMO 2024 and published in the New England Journal of Medicine.

Final CABINET Phase III trial data showed Cabometyx significantly reduced disease progression or death risk in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NETs) compared to placebo, presented at ESMO 2024 and published in NEJM. Ipsen has submitted an extension of indication Marketing Authorization to the EMA, addressing limited treatment options for advanced NETs.

CONTACT-02 trial showed Cabometyx® + atezolizumab had a positive trend in overall survival but lacked statistical significance. Ipsen will not pursue regulatory submissions for this combination outside the US and Japan. Confidence remains in Cabometyx's profile as a monotherapy and in combination with immunotherapy.

Ipsen announced final overall survival data from Phase III CONTACT-02 trial, showing a numerical but not statistically significant improvement in OS for Cabometyx® (cabozantinib) plus atezolizumab in metastatic castration-resistant prostate cancer (mCRPC). The trial met the primary endpoint of progression-free survival (PFS). Based on these results, Ipsen will not pursue regulatory submissions for this combination regimen outside the US and Japan. Ipsen remains confident in Cabometyx's profile as a monotherapy and in combination with immunotherapy.

Various researchers report financial relationships with pharmaceutical companies, including Deciphera, during and outside the conduct of the study.

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Ipsen employee Dishant Gupta charged with insider trading after allegedly profiting from stock transactions based on non-public knowledge of the company's $247 million buyout of Epizyme. Gupta, who agreed to plead guilty, faces a monetary penalty and is barred from serving as an executive or director of any publicly traded company. Ipsen's oncology portfolio expansion includes acquisitions like Epizyme's Tazverik and Merrimack Pharmaceuticals' Onivyde, along with deals for cancer drug development programs.